nafarelin acetate spray - nasal, Synarel (cont.)
SIDE EFFECTS: Nasal irritation, hot flashes, vaginal discharge, or mood swings may occur in children. Nasal irritation, hot flashes, headaches, mood swings, decreased sexual interest, muscle pain, vaginal dryness, acne, or decrease in breast size may occur in women. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.For women taking this medication, tell your doctor immediately if any of these unlikely but serious side effects occur: abdominal/lower back pain, bone pain, depression.For women taking this medication, tell your doctor immediately if any of these rare but very serious side effects occur: fast/pounding heartbeat, numbness/tingling of arms/legs, eye pain.Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (e.g., leuprolide); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unexplained abnormal vaginal bleeding.Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels.This medication must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. Women should start this medication between days 2 and 4 of their period. Although periods and the release of eggs (ovulation) may stop while you are taking this drug, this should not be considered a reliable form of birth control. It is recommended that men and women using this medication use two effective non-hormonal forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Consult your doctor.It is not known if this medication passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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